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Showing 2681–2700 of 68218 results

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Coconut Macaroon Cookie (New Grains) – undeclared allergens (2025)

Due to printing quality, label does not declare these allergens clearly: Egg, Milk, Soy.

FDAApr 23, 2025UT• NEW GRAINS GLUTEN FREE BAKERY

Chocolate Chip Cookie (New Grains) – undeclared allergens (2025)

Due to printing quality, label does not declare these allergens clearly: Egg, Milk, Soy.

FDAApr 23, 2025UT• NEW GRAINS GLUTEN FREE BAKERY

Plain Bagels (New Grains) – undeclared egg (2025)

Due to printing quality, label does not declare Egg allergen clearly.

Class IHigh

FDAApr 23, 2025UT• NEW GRAINS GLUTEN FREE BAKERY

Endopath Echelon Vascular Reload (Ethicon) – Instrument Lockout (2025)

Laceration Risk

Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.

FDAApr 22, 2025Nationwide• Ethicon Endo-Surgery Inc

Plum Solos Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

FDAApr 22, 2025Nationwide• ICU Medical, Inc.

Codman Disposable Perforator Kit (Medline) – Weld Inadequacy (2025)

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

FDAApr 22, 2025CA, FL, IL +10 more• MEDLINE INDUSTRIES, LP Northfield

Catalyst+ C4D Software (C-RAD) – Scanning Equipment Error (2025)

Software issue with scanning equipment that can results in the filed rotation not being applied correctly.

FDAApr 22, 2025Nationwide• C-RAD POSITIONING AB Bredgrand 18 Uppsala Sweden

3M Ranger Irrigation Set (3M) – Flow Rate Clarification (2025)

Notice was issued to clarify flow rates related to the inlet fluid temperature.

FDAApr 22, 2025Nationwide• 3M Company

Clindamycin HCl Capsules (RemedyRePack) - CGMP Issues (2025)

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

Class IIModerate

FDAApr 22, 2025FL, PA, VA• RemedyRePack Inc.

Plum Duo Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

FDAApr 22, 2025Nationwide• ICU Medical, Inc.

Lower Extremity Implant (American Contract) – EO/ECH Residuals (2025)

Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.

FDAApr 21, 2025Nationwide• American Contract Systems, Inc.

BIB Balloon Catheter (Numed) – Labeling Error (2025)

Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.

FDAApr 21, 2025PA• Numed Inc

BD Cathena IV Catheter (BD) – Septum Defect Risk (2025)

Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.

FDAApr 21, 2025Nationwide• Becton Dickinson Infusion Therapy Systems, Inc.

Precision Sampling Set (Capnia) – Contamination Risk (2025)

Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.

FDAApr 21, 2025Nationwide• Capnia Inc

Tirofiban Hydrochloride Injection (Eugia US) - Stability Concern (2025)

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Class IIModerate

FDAApr 21, 2025Nationwide• Eugia US LLC

EVENITY Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

BENLYSTA Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

PROLIA Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

Monkfish Liver (JJWV Marketing) – Undeclared Milk (2025)

Undeclared Allergen

Undeclared allergen ingredient (milk)

FDAApr 21, 2025CA• JJWV Marketing Corporation

Tirofiban Hydrochloride Injection (Eugia US) - Stability Concern (2025)

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Class IIModerate

FDAApr 21, 2025Nationwide• Eugia US LLC

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